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Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study

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ClinicalTrials.gov Identifier: NCT04802005
Recruitment Status : Withdrawn (PI moved to another institution)
First Posted : March 17, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Maria Fernandez Del Valle, Southern Illinois University Edwardsville

Study Description
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Brief Summary:
The overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging.

Condition or disease Intervention/treatment Phase
Obesity Other: Aerobic Interval Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study
Actual Study Start Date : March 16, 2021
Actual Primary Completion Date : April 16, 2021
Actual Study Completion Date : April 16, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Aerobic interval
Aerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure (target expenditure ~450-500kcal/session). Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity at 70-85% of predicted HRmax, and for the second period the intensity will be reduced to 60-65% of predicted HRmax for 2 minutes. The training sessions will be carried out outdoors at the trails located on campus. The activity will consist of walking and/or light jogging. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion (RPE) as needed. The RPE for the first period range will be 13-17 (15-17 at the end of the period) and 10-12 for the second period.
 Other: Aerobic Interval Training
The aerobic interval training group
No Intervention: Control group
Participants in the control group will not participate in the training programs.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Cardiac Adipose Tissue (CAT) [ Time Frame: 2 assessment points: at baseline and week 5 ]
    CAT will be measured using cardiac Magnetic Resonance

  2. Changes in Cardiac Function [ Time Frame: 2 assessment points: at baseline and week 5 ]
    Cardiac Function will be measured using cardiac Magnetic Resonance


Secondary Outcome Measures :
  1. Changes in Body Composition [ Time Frame: 2 assessment points: at baseline and week 5 ]
    Body composition will be measured using dual-energy x-ray absorptiometry

  2. Changes in Cardiorespiratory Function [ Time Frame: 2 assessment points: at baseline and week 5 ]
    Cardiorespiratory Function will be measured on a treadmill with a metabolic cart

  3. Changes in Muscular Strength [ Time Frame: 2 assessment points: at baseline and week 5 ]
    Muscular Strength will be assessed through 1 repetition maximum (1RM).

  4. Changes in Blood Pressure [ Time Frame: 2 assessment points: at baseline and week 5 ]
    Blood pressure will be measured using pulse wave analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • females, age 18-40 years old, body mass index (BMI) ≥ 30 kg/m2 and < 39.9 kg/m2, without known metabolic and/or cardiovascular disease

Exclusion Criteria:

  • known CV, metabolic or pulmonary diseases or conditions, muscular-skeletal injuries (i.e. spine, knees, hips or shoulders, taking medications that affect endocrine or cardiovascular function, hypertension, being engaged in moderate intensity exercise more than two times per week or moderate-high intensity training of any type and frequency, being pregnant, cigarette smoking, having non-removable pieces or devices incompatible with DXA and CMR assessment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802005


Locations
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United States, Illinois
Southern Illinois University Edwardsville
Edwardsville, Illinois, United States, 62026
Sponsors and Collaborators
Southern Illinois University Edwardsville
Investigators
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Principal Investigator: Maria Fernandez Del Valle, PhD Southern Illinois University of Edwardsville
More Information
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Responsible Party: Maria Fernandez Del Valle, Principal Investigator, Southern Illinois University Edwardsville
ClinicalTrials.gov Identifier: NCT04802005    
Other Study ID Numbers: 1063
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Fernandez Del Valle, Southern Illinois University Edwardsville:
Cardiac fat
Cardiac function
Aerobic interval training
Cardiac Magnetic Resonance
Vascular health
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight